Events

Hospira GemStar Docking station 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Hospira Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    15721
  • 사례 시작날짜
    2013-11-29
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • 데이터 추가 비고
    Recalling Organisation: Hospira NZ Ltd, 58 Richard Pearse Drive, Airport Oaks, Mangere, Auckland 2022
  • 원인
    Hospira inc. has become aware of two situations that may occur when using the gemstar docking station list numbers 13075-xx-07 and 13075-xx-09 in conjunction with the gemstar infusion pump., when the docking station is used in conjunction with a gemstar phase 3 infusion pump (list numbers 13000-xx, 13100-xx or 13150-xx), the potential exists for the pump to fail to power up while connected to the docking station., when a gemstar phase 4 infusion pump (list numbers 13086-xx, 13087-xx or 13088-xx) is used in conjunction with both a docking station and an external battery pack accessory (list 13073-xx), there exists a possibility that the gemstar pump will display error code 11/003 indicating excessive input voltage from the external sources. the 11/003 error code will stop infusion if the error occurs when an infusion is in process.
  • 조치
    Instructions for use to be updated

Device

Hospira GemStar Docking station

Manufacturer

Hospira Inc
  • 제조사 모회사 (2017)
    Pfizer
  • Source
    NZMMDSA